prasugrel

Is Lilly's prasugrel safe?

Christe Bruderlin-Nelson — Wed, 12 Nov 2008 01:22:15 -0500

FDA has been delaying approval of Eli Lilly's experimental medication, Prasugrel, amidst concerns about bleeding problems. The company has been awaiting FDA approval since it submitted the highly-anticipated medication for review last December. Prasugrel is a direct competitor of Plavix, and an early clinical trial showed that is was better than the top-selling blood thinner at preventing blood clots. Unfortunately, it seems to come with a higher risk of bleeding, too.

Researchers for Lilly say that the medication is safe as long as physicians are careful not to prescribe it to patients at high risk for bleeding. Those include patients who weigh less than 130 pounds, patients who are 75 years old or older and patients with a history of stroke. Others say the data are not clear enough to determine which types of patients could take Prasugrel safely.

Industry insiders are watching the potential blockbuster drug closely, but it could be months, or even years, before FDA approves the medication if the company does not find a way to reduce the bleeding risk.

- read the Pharmalot blog post

Stent, drug makers team up on clot study

Tracy Staton — Thu, 16 Oct 2008 11:06:27 -0400

Stent makers and the drugmakers who treat their patients want to settle the clotting question once and for all. So device and pharma companies are joining forces on a major trial to test blood-thinner use in stent patients. And when we say major, we mean major: four years; 20,000 patients; $100 million.

The trial will test whether stent patients should take clot-busters for one year after the device is placed, or for at least two and one-half years afterward. Abbott Laboratories, Medtronic, Boston Scientific and Johnson & Johnson are holding up the stent side of the equation. Sanofi-Aventis and Bristol-Myers Squibb, which co-market Plavix, will participate on the drug side, along with Eli Lilly and Daiichi Sankyo, whose potential Plavix competitor prasugrel is waiting in the FDA approval queue.

The aim is to develop a stent-and-drug protocol that might quell worries about blood clots. You'll recall the brouhaha over the safety of drug-eluting stents versus bare stents, and over stents versus drug treatment. Well, FDA asked stent and drug makers to determine the best clot-prevention approach. As Bram Zuckerman, an FDA official who helped lay the groundwork for the study, told the Wall Street Journal, "The results will lead to greater clarity of an extremely important problem."

- see the story at the WSJ Health Blog
- check out the WSJ article

Setback for Lilly, gain for Plavix?

Tracy Staton — Tue, 24 Jun 2008 09:16:20 -0400

When FDA delayed its decision on Eli Lilly's clot-buster prasugrel, a.k.a. Effient, it sliced at least three months off the time Lilly might have to win market share from the commonly used blood thinner Plavix. Doing so quickly is crucial, because Bristol-Myers Squibb and Sanofi-Aventis' Plavix goes off patent by 2011--and cheap generic versions are likely to drain away even more of the market. Report